MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CREATININE

Catalog Number	07P99-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely elevated creatinine results on one patient generated on the alinity c analyzer.The results provided were: on (b)(6) 2019: sid (b)(6) initial = 1.04mg/dl / repeated on sid (b)(6) on (b)(6) 2019 = 2.00 / repeated on (b)(6) 2019 = 1.35mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 82628un18.The search found no other tickets or trends for the complaint issue.Return testing was not completed as returns were not available.Per the text of the ticket, a precision study was performed with 10 creatinine replicates and was found to be acceptable.The alinity ci-series system operations manual provides adequate instructions for maintenance of and cleaning the water bath and cuvettes.Based on the investigation no product deficiency was identified for the alinity c creatinine reagent, lot 82628un18.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8691838
• Report Number: 3002809144-2019-00322
• Device Sequence Number: 19290511
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2019
• Device Catalogue Number: 07P99-20
• Device Lot Number: 82628UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C PROCESSING MODULE, LN 03R67-01; ALINITY C PROCESSING MODULE, LN 03R67-01; SERIAL # (B)(4); SERIAL # (B)(4)